Class II U.S. Food and Drug Administration

Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 16G recall: There was an error in inspection and programming of the eTRAX needle sensor

Recall published 7 months ago

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1733-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Civco Medical Instruments Co. Inc.
Product type
Medical devices
Units affected
18 units
Distribution
Ohio, Pennsylvania, Washington
Made in
United States
Lot / code info
UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
UPC codes
00841436111058

Products covered by this recall

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00841436111058

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • A228675
  • A228676
  • A233854
  • A268115
  • A268237
  • A272509
  • A277538
  • A280341

Model or item number

On the rating label, the box or the instruction sheet.

  • 667-151 — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Civco Medical Instruments Co. Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Civco Medical Instruments Co. Inc. — 102 1st St S, Kalona, IA, 52247-9589

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Civco Medical Instruments Co. Inc. medical devices recalled?

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00841436111058; lot code A228675, A228676, A233854; model number 667-151 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Ohio, Pennsylvania, Washington.

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